The following data is part of a premarket notification filed by Sakae Corporation with the FDA for A1c Gear System.
| Device ID | K130014 |
| 510k Number | K130014 |
| Device Name: | A1C GEAR SYSTEM |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | Sakae Corporation 575 Shirlynn Court Los Altos, CA 94022 |
| Contact | Erica B Ammirati |
| Correspondent | Erica B Ammirati Sakae Corporation 575 Shirlynn Court Los Altos, CA 94022 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-02 |
| Decision Date | 2014-04-04 |
| Summary: | summary |